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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Bandtite Band Cement - 00190746007859

BANDTITE GLASS IONOMER CEMENT MINI KIT
AMERICAN ORTHODONTICS CORPORATION
001-970M
Not in Commercial Distribution

  • 00190746007859 ()
001-970M

  • Orthodontic bracket adhesive

Bandtite Band Cement - 00190746007842

BANDTITE GLASS IONOMER CEMENT KIT
AMERICAN ORTHODONTICS CORPORATION
001-970
In Commercial Distribution

  • 00190746007842 ()
001-970

  • Orthodontic bracket adhesive

Silan-IT - 03760260223119

Cross-linking agent containing silan agent to improve adhesion
ITENA CLINICAL
SILAN-IT
In Commercial Distribution

  • 03760260223119 ()


  • Dental prosthesis priming agent

Onyx HD 500 - 00836462005129

105-8101-500 ONYX HD500 KIT ANEURYS
Micro Therapeutics, Inc.
105-8101-500
In Commercial Distribution

  • 00836462005129 ()


  • Neurovascular embolization plug

Enamelize™ - EDEL9060000

Enamelize™, Syringe 3g
DeltaMed GmbH
906000
In Commercial Distribution

906000

  • Dentifrice

Renamel® Flowable Microhybrid - EDEL7011MI0

Renamel® Flowable Microhybrid Medium Incisal, Syringe 3g
DeltaMed GmbH
7011MI
In Commercial Distribution

7011MI

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011D30

Renamel® Flowable Microhybrid Body D3, Syringe 3g
DeltaMed GmbH
7011D3
In Commercial Distribution

7011D3

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011B30

Renamel® Flowable Microhybrid Body B3, Syringe 3g
DeltaMed GmbH
7011B3
In Commercial Distribution

7011B3

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011B10

Renamel® Flowable Microhybrid Body B1, Syringe 3g
DeltaMed GmbH
7011B1
In Commercial Distribution

7011B1

  • Dental composite resin

Renamel® Flowable Microhybrid - EDEL7011A20

Renamel® Flowable Microhybrid Body A2, Syringe 3g
DeltaMed GmbH
7011A2
In Commercial Distribution

7011A2

  • Dental composite resin
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